Medical equipment

IEC 62304 is an international harmonized standard that provides guidance to the manufacturer on the planning, development and post-market surveillance activities for medical device software to ensure that companies comply with the requirements of international regulatory agencies. Its first version was published in 2006 […]

Equipment software lifecycle process...

in ISO/IEC / Without category tagged software life cycle / engineering / medical engineering / Medical equipment / Software Lifecycle Process / Program / software by
The FMEA analysis aims to identify potential failure modes of a product or process in order to assess the risk associated with these failure modes so that they are classified in terms of importance and then receive corrective actions in order to reduce the incidence of failures . […]

FMEA- Analysis of Failure Modes and Effects

in Risk management / SESBO tagged Analysis / Analysis of Failure Modes and Effects / electronics / engineering / Clinical Engineering / Medical equipment / FMEA / Microelectronics by